Neo-nervegenesis in Inguinal Hernia Implant ProFlor

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-12-31

Brief Summary

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The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.

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Detailed Description

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Biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the presence, quantity and quality of the neural ingrowth within the implant fabric. Histology revealed the presence of multiple nerve clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, neural elements assumed the typical aspect of normal nervous structures complete in all components. The development of highly specialized tissue such as nerves, together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. This kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Short term post inguinal hernia repair wit ProFlor

Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-5 weeks post implantation

Group Type ACTIVE_COMPARATOR

ProFlor Hernia implant

Intervention Type DEVICE

Inguinal hernia repair

Mid term post inguinal hernia repair wit ProFlor

Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-4 months post implantation

Group Type ACTIVE_COMPARATOR

ProFlor Hernia implant

Intervention Type DEVICE

Inguinal hernia repair

Long term post inguinal hernia repair wit ProFlor

Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 6-8 months post implantation

Group Type ACTIVE_COMPARATOR

ProFlor Hernia implant

Intervention Type DEVICE

Inguinal hernia repair

Interventions

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ProFlor Hernia implant

Inguinal hernia repair

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor
* Patients undergoing recurrent inguinal hernia repair after primary repair with the prosthetic device named ProFlor
* Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the prosthetic device named ProFlor